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U.S. Department of Health and Human Services

Enforcement Report - Week of February 6, 2013

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Product Detail

Product Description COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Recall Number Z-0762-2013
Classification Class II
Code Info Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.
Product Distributed Qty 335 CE-IVD TDFs; 48 JPN-IVD TDFs
Reason For Recall The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.

Event Detail

Event Id 63997
Product Type Devices
Status Ongoing
Recalling Firm Roche Molecular Systems, Inc.
City Branchburg
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-28
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)
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